Genedata Selector 9.0 Automates Critical Quality Attribute Assessment of Cell and Gene Therapy Products

Major software update enables biopharma R&D organizations to adopt innovative NGS-driven assays to confirm identity, integrity, potency, and safety throughout CGT product development and deploy them within a GMP-compliant environment

August 3, 2023
Basel, Switzerland

Genedata, the leading provider of enterprise software solutions for biopharmaceutical R&D, today announced a new release of Genedata Selector^®, the collaborative end-to-end solution that provides quality control automation support to companies striving to make safe and efficacious cell and gene therapies more accessible to patients worldwide. 

Genedata Selector is an enterprise platform that automates the identification and monitoring of critical quality attributes during cell and gene therapy development and manufacturing. Equipped with out-of-the-box workflows named Playbooks, the platform enables scientists to perform data analyses accurately and efficiently, independent of data analysts. Bioinformaticians can include proprietary workflows for NGS data processing and analysis and make them available across an organization facilitating automation and improved process standardization. As a modular platform with sample management capabilities, Genedata Selector facilitates sample tracking and provides user-friendly decision-making tools that support in-depth analysis of pass/fail samples. 

Selector 9, the latest release, focuses on providing specialized analytical workflows for biotherapeutic characterization and adventitious agent detection to meet required regulatory standards. In particular, this release has eliminated data handling redundancies and further improved the interoperability of Genedata Selector, for example by enabling easy integration of proprietary Nextflow pipelines into the platform for NGS data processing. This enables users to benefit from best practices for developing innovative cell and gene therapy products. Finally, the tighter integration with high-performance computing environments enables Genedata Selector users to manage system resources while gaining scalability and power. 

Genedata Selector is fully compliant with FAIR (Findable, Accessible, Interoperable, and Reusable) data principles. During CGT product development, biopharmaceutical R&D organizations gather large volumes of highly diverse experimental data, for which Genedata Selector provides a centralized location that integrates those data and connects them to their respective sample metadata. Teams involved in product development can easily access these data, to for example monitor changes in critical quality attributes and make data-informed decisions about which products should proceed in the manufacturing process. Additionally, Genedata Selector is validation-ready for deployment in GxP environments, and if required, Genedata can also provide computer system validation support.

“With Genedata Selector 9, we have made another major step forward in our goal to enable innovative biopharmaceutical R&D organizations to decrease the time-to-market of life-changing cell and gene therapy products. With its best-in-class analytical capabilities, Genedata Selector enables the biopharma industry to apply NGS and efficiently monitor product quality during bioprocess development and product manufacturing”, said Othmar Pfannes, Ph.D., CEO of Genedata. “We will continue to invest in further accelerating experimental workflows and automating complex data analytical processes to help our customers efficiently develop biotherapeutics of the highest quality.”